It is now generally acknowledged that indwelling catheterization in medical, surgical, gynecological, and urological patients often leads to serious infections of the urogenital tract. Indwelling urethral catheterization is performed in approximately 10 to 15 percent of hospitalized patients. Despite the use of the most careful aseptic technologies undertaken, while the catheter is in the patient, approximately fifty percent of the patients develop an infection, when a catheter is in place for twenty four hours or longer. Catheterization is harmful to the patient because (s)he is subjected to the risk of cystiris, acute pyelonephiritis and life-threatening septicemia, which infections carry a risk of mortality, as reported in Arch. Internal Med., Vol. 110, pp 703-11, (1962); Antimicrob. Agents Chemother., pp 617-23, (1963); and Lancet, Vol. 1, pp 310-12 (1960).
The occurrence of the above-mentioned infections is encouraged by many circumstances. These circumstances include prolonged use of indwelling Foley catheters often accompanied by the absence of a sterile insertion and maintenance technique, and by having the catheter connected to a clean, but not sterile drainage collection container placed in the immediate vicinity of the patient's bed. These conditions and other circumstances predispose a patient to infection as reported in Urinary Tract Infection and Its Management, edited by Kaye, D., Chapter 15, "care of the Indwelling Catheter," pp 256-66, (1972), published by the C. V. Mosby Company, St. Louis, Mo.,; and in "Factors Predisposing to Bacteriuria During Indwelling Urethral Catheterization," New Eng. J. Med., Vol. 291, pp 215-23, (1974).
The prior art noted attempts have been made to reduce the incidence of catheter acquired infections and to reduce the presence of unwanted organisms in drainage containers, but these attempts have not met with general acceptance. For example, one attempt consists in systemic chemoprophylaxis achieved by orally administering an antibiotic such as chloramphenicol, penicillin or streptomycin. This attempt, however, affords no significant protection against the acquisition after indwelling catheterization, as reported in Arch. Internal Med., Vol. 110, pp 703-11, (1962); Acta Chiv. Scand., Vol. 118, pp 45-52 (1959); and Dis. Mon., pp 1-36, (Sept. 1960).
The medical and the patent literature are illustrative of attempts to eliminate the urinary drainage bag as a source of contamination leading to urinary tract infection. These attempts for preventing or substantially eliminating unwanted organisms include adding a biocide during manufacture to a drainage container, or placing a device inside the container wherein the device releases a biocide. For example, liquid formalin is added to the urine collection container for controlling, that is, killing pathogens. This method, however, does not enjoy general use because there is a risk of siphoning formalin into the urinary tract, as reported in British Med. J., Vol. 2, pp 4233-25, (1964). In U.S. Pat. No. 4,233,263 the patentee Shaeffer disclosed adding 3% hydrogen peroxide solution to a urine bag for reducing the risk of urinary tract infection. This method is inherently subjected to poor results because of a lack of compliance. That is, each time urine is declined from the urinary drainage bag the hydrogen peroxide is drained and the solution must be reintroduced into the urine bag. This procedure requires mixing and agitation, and it is often accompanied by spilling of the solution. Also, hydrogen peroxide loses its strength over time.
The prior art, in U.S. Pat. Nos. 4,193,403 and 4,241,733 Langston et al discloses a device inside an urinary drainage bag. The device contains paraformaldehyde that depolymerizes to formaldehyde in the presence of moisture inside the urine drainage bag. While formaldehyde is an antimicrobial, it is not used because it may be injurious to an animal host. In U.S. Pat. No. 3,312,221 patentee overment discloses an urinary drainage bag having a porous plastic internal pouch containing an antimicrobial agent. The pouch is suspended so that incoming urine cascades over and through the pouch so that the antimicrobial agent will dissolve in the urine. However, an adequate dwell time of the antimicrobial agent in the urine is not assured by the quick flow process. Thus, the urine is undersatinated with antimicrobial agent with a high flow rate of urine into the urine container.
In view of the above presentation, it will be appreciated by those versed in the urinary drainage art, that a critical need exists for a novel and unique means for introducing an antimicrobial agent into an urinary container. The need exists for overcoming the difficulties associated with the prior art use of a preplaced delivery device inside the container, that exhaust itself of antimicrobial agent and is non-replaceable from outside with present, closed urinary drainage systems. It will thus be appreciated that a pressing need exists for a means that can be introduced into the container from outside the container for providing an antimicrobial agent in the container.